Multicenter, Phase III, Open-Label, Uncontrolled Study to Assess the Safety and Efficacy of a Single Oral Dose of Palonosetron 0.75 mg in the Prevention of Chemotherapy Induced Nausea and Vomiting in Cancer Patients Undergoing Repeated Cycles of Moderately Emetogenic Chemotherapy
- Conditions
- Moderately emetogenic chemotherapy induced nausea and vomiting
- Registration Number
- EUCTR2005-001944-21-CZ
- Lead Sponsor
- Helsinn Healthcare SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1.Male or female, >/= 18 years of age
2.Histologically or cytologically confirmed malignant disease
3.Patient scheduled to receive repeated and consecutive moderately emetogenic chemotherapy cycles employing the same basic moderately emetogenic regimen (single or multi-drug regimen). This can include changes in dose or discontinuation of concomitant chemotherapeutic agents as clinically appropriate, as long as the agent that defines the regimen as moderately emetogenic is still included and no highly emetogenic agents are added.
4.Naïve or non-naïve to cancer chemotherapy (see Section 3.1 for definition)
5.If a patient is non-naïve before the first study cycle, he/she must have experienced no more than mild nausea and no vomiting following any previous chemotherapy cycle
6.A Karnofsky index of >/= 50%
7.Scheduled to receive a single intravenous dose of at least one of the following moderately emetogenic agents administered on Day 1:
•any dose of oxaliplatin, carboplatin, epirubicin, idarubicin, doxorubicin, ifosfamide, irinotecan or daunorubicin or
•cyclophosphamide <1500 mg/m2 or cytarabine >1g/m2
8.Patient scheduled to receive the most emetogenic chemotherapeutic agent during a maximum of 4 hours
9.Written informed consent (with additional legal representative’s or parent’s consent if required)
10.If a patient has a known hepatic, renal or cardiovascular impairment and is scheduled to receive the above mentioned chemotherapeutic agents, he/she may be enrolled in this study at the discretion of the Investigator.
11.If a patient has a known history or predisposition to cardiac conduction interval abnormalities, including QTc, he/she may be enrolled in this study at the discretion of the Investigator.
12.If a patient is female of childbearing potential, she must be using reliable contraceptive measures with a negative pregnancy test before any study treatment administration.
13.The time interval between two consecutive study drug administrations (between the two ‘Day 1’ days in two consecutive study cycles) must be at least seven days (i.e. study drug can be administered at weekly intervals).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Inability to understand or cooperate with the study procedures
2.Any investigational drugs within 30 days before study entry
3.Any drug with potential anti-emetic efficacy within 24 hours of the intake of study treatment. Examples of these drugs are: 5 HT3 receptor antagonists, aprepitant, metoclopramide, phenothiazine anti-emetics (such as prochlorperazine, thiethylperazine and perphenazine), scopolamine, diphenhydramine, chlorpheniramine maleate, trimethobenzamide, all benzodiazepines except triazolam or zolpidem used once nightly for sleep, haloperidol, droperidol, tetrahydrocannabinol, or nabilone, any corticosteroid such as dexamethasone, hydrocortisone, methylprednisolone and prednisone. Patients taking topical or inhaled steroids may be enrolled in the study.
4.Any antacid medication within 24 hours of the intake of study treatment
5.Any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy
6.Treatment with US, EU or Mexican commercially available IV palonosetron 0.25 mg (Aloxi®; Onicit®) within two weeks prior to the intake of study treatment
7.Enrollment in a previous study with palonosetron
8.Ongoing vomiting from any organic etiology
9.Presence of a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication (prophylactic anticonvulsant medication for patients free of seizure activity is allowed)
10.Palonosetron 0.75 mg not administered in consecutive chemotherapy cycles, i.e. if a chemotherapy cycle is performed without oral palonosetron 0.75 mg administration after the patient has already received at least one preceding cycle in this study (including palonosetron 0.75 mg), the patient has to be excluded from further participation in the study.
11.Scheduled to receive:
•Moderately emetogenic chemotherapy within 7 days prior to the study, on Days 2-5 of each study cycle, or on any day between two consecutive cycles
•Orally or intravenously: any dose of cisplatin, dacarbazine, streptozotocin, carmustine, mechlorethamine, hexamethylmelamine or procarbazine; or cyclophosphamide >/= 1500 mg/m2 within 7 days prior to the study or during the study (see also Appendix E)
•Radiotherapy of upper abdomen or cranium or total body irradiation within
7 days prior to the study or during the study
•Docetaxel, paclitaxel or pemetrexed on Day 1 in association with corticosteroids for the prevention of hypersensitivity reactions
•Any low-level emetogenic chemotherapeutic agent during Days 2 to 5 of each study cycle, if this chemotherapy, in the Investigators’ opinion, requires co-administration of antiemetics. Administration of low-level emetogenic chemotherapy without antiemetics is allowed on Days 2 to 5 (see also Appendix E).
12.Known contraindication to 5-HT3 receptor antagonists
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method